drugset / Trial / NCT02457221

A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

NCT02457221

Phase 3 Completed 314 enrolled Astellas Pharma Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.

Timeline

Start
2015-03-10
Primary completion
2018-09-10
Completion
2018-09-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified Intravenous
Subject Tacrolimus Small molecule Oral
Background Prednisone Other / unclassified Oral

Indications